The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe 2991 Supplementary Disposable Sets.
| Device ID | K893962 |
| 510k Number | K893962 |
| Device Name: | COBE 2991 SUPPLEMENTARY DISPOSABLE SETS |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Mary Armstrong |
| Correspondent | Mary Armstrong COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-02 |
| Decision Date | 1989-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583909121 | K893962 | 000 |
| 35020583909046 | K893962 | 000 |
| 35020583909015 | K893962 | 000 |
| 05020583909120 | K893962 | 000 |
| 05020583909045 | K893962 | 000 |
| 05020583909014 | K893962 | 000 |
| 05020583910003 | K893962 | 000 |